Efficacy of misoprostol in the treatment of tinnitus in patients with diabetes and/or hypertension

Objective: To determine the efficacy of the prostaglandin El analogue misoprostol in the treatment of tinnitus in diabetic and/or hypertensive patients. Design: Double-blind, randomized, placebo-controlled trial. Settings: Tertiary care referral center. Methods: The subjects were 42 patients with hypertension and/or diabetes mellitus who had chronic tinnitus and had experienced tinnitus symptoms for a minimum of 6 months. Twenty-eight patients were randomly assigned to Group I (misoprostol treatment), and 14 patients to the Group II (placebo treatment). Misoprostol therapy was started at 200 mug per day, and was increased 200 mug every 7 days until a dose of 800 mug per day was reached. The same numbers of placebo tablets were given to the control group using the same schedule. Both groups were treated for 1 month. The changes in objective and subjective tinnitus findings from baseline to 1 month were assessed, and the group results were compared. The chi(2)-test, student's t-test and paired-samples t-test were used to analyze the study. Results: At the completion of treatment, objective assessment showed that tinnitus loudness decreased in 13 (46%) of the 28 patients in the experimental group, whereas this was observed in only two (14%) of the 14 subjects in the placebo group. Subjective tinnitus scoring revealed improvement rates of 29 and 14% for the misoprostol and placebo groups, respectively. When t-test relating to difference between rates were performed, the difference between improvement rate for tinnitus loudness of the experimental group and control group was found to be statistically significant (P = 0.05), but difference between improvement rate based on subjective tinnitus scoring was insignificant (P = 0.22). Conclusion: Misoprostol is an effective and safe treatment for chronic tinnitus in hypertensive and/or diabetic patients. Our results are encouraging, but further studies of larger series are needed. (C) 2004 Elsevier Ireland Ltd. All rights reserved.